Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

Recall Number: D-1445-2020

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class III

Status: Terminated

Report Date: 20200805

Initiation Date: 20200706

Termination Date: 20230608

Reason for Recall

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Product Description

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86